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Heroin Deaths Double in the Past Two Years

From: Bloomberg News

The number of Americans dying from heroin overdoses doubled across 28 states in 2012 from 2010, according to the Centers for Disease Control and Prevention, fueled by easy access and rising rates of opioid addiction.

The unusual analysis published today in the CDC’s weekly bulletin stemmed from the agency’s effort to determine if reports from some states about spikes in heroin use and related deaths since 2010 were part of a larger nationwide trend. They found a growing problem with fatal overdoses of heroin.

Health officials have focused in recent years on reducing abuse of prescription opioid painkillers, such as OxyContin. Overdoses of those medicines quadrupled from 1999 through 2010, while heroin, a cheaper and more available alternative, increased by less than 50 percent. The report confirms heroin has made a comeback in 28 states, as noted by Vermont Governor Peter Shumlin who said in January his state was in a “full-blown heroin crisis.”

Deaths from heroin overdoses rose across the board: in both genders, all ages, all racial and ethnic groups and all regions of the country, the CDC report found.

“The findings indicate a need for intensified prevention efforts aimed at reducing overdose deaths from all types of opioids,” the report found. “Efforts to prevent expansion of the number of opioid pain reliever users who might use heroin when it is available should continue.”

Death Toll

There were 3,635 heroin deaths in 2012, an increase from 1,779 two years earlier. While the crackdown on opioid abuse may have led users to heroin, painkillers are still more deadly. Opioid overdoses killed 9,869 Americans in 2012, down 5.4 percent from 2010.

Additional data suggests that prescription painkillers may be a gateway drug to heroin use, the report said. Three-quarters of patients in a rehabilitation program who started using heroin after 2000 said the first opioid they took was a prescription medication. More than 80 percent of people who began using heroin in the 1960s said they started with the drug.

“Reducing inappropriate opioid prescribing remains a crucial public health strategy to address both prescription opioid and heroin overdoses,” said CDC Director Thomas Frieden. “Addressing prescription opioid abuse by changing prescribing is likely to prevent heroin use in the long term.”

DEA Further Restricts Hydrocodone Combination Products

From: Medscape

The US Drug Enforcement Administration (DEA) voted today (Aug 21) to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to hand HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.


"Unreal" Overdose Spike Has Officials Ready to Fight Opioid Drugs

From NBC10 Philadelphia:

An alarming number of drug overdoses has officials in one Bucks County township gearing up for a fight.

In the past month, 63 people have overdosed in Bensalem, Pa. on opioid drugs like heroin and prescription pain killers that include oxycodone and vicodin says township Director of Public Safety Fred Harran.

While heroin is widely known as a dangerous and severely addictive narcotic that’s long been a target of the war on drugs, Harran says it’s the prescription painkillers that are a bigger source of concern.

Between 80 and 90-percent of the crimes committed in the town are tied in one way to drugs, according to Harran. He says the drug seekers are both a mix of local residents and visitors traveling to the town to get high.

Harran and other public safety officials have been meeting to determine an attack plan to cut down on drug use and availability. The director says he’s not ready to release every detail about the plan, but said the department’s actions would be "groundbreaking."

A new report released on Monday from the Trust for America’s Health found Pennsylvania has the 14th highest rate of drug overdose deaths. The report found the Commonwealth had 15.3 overdose deaths per 100,000 residents in 2010. Most of those deaths involved the use of prescription drugs.

In Philadelphia, city officials have seen what they call a startling spike in addiction rates, deaths and confiscations by police of opioids like prescription pills and heroin.

Nationally, drug overdose is the leading cause of injury death in the United States, according to the Centers for Disease Control and Prevention. Drug overdose deaths have jumped 102-percent from 1999 to 2010 and as of the last reporting in 2010, 60-percent of those deaths were related to pharmaceuticals.

The CDC also found that of the 38,329 overdose deaths in 2010 that involved pharmaceuticals, 75-percent involved some form of opioid.

Abuse-resistant OxyContin will be only version available: FDA

From the Los Angeles Times:

Three years after it approved a version of the opioid analgesic OxyContin designed to discourage the painkiller's abuse, the Food and Drug Administration has effectively barred the original form of the drug from ever reaching the legal U.S. market. The agency says it will approve no new applications from generic drug manufacturers to produce cheaper versions of OxyContin in its original form.

OxyContin has been one of the nation's most abused prescription painkillers, in part because as those addicted to the potent drug built up tolerance for it, they could easily ground it up or dissolve it in water, making the potent extended-release drug easy to snort or inject for a faster, more intense high.

But in April of 2010, the FDA approved a reformulated version of the drug that was resistant to crushing, breaking, chewing or dissolving in water. The newer version is virtually unbreakable, and when dissolved in water, turns into a jelly-like mass.

Posted: 4/17/2013 10:55:00 AM

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Opana abuse in USA overtakes OxyContin

From USA Today:

Prescription drug abuse is the nation's fastest-growing drug problem, the White House Office on National Drug Policy says. The Centers for Disease Control and Prevention has classified the misuse of these powerful painkillers as an epidemic, with 1.3 million emergency room visits in 2010, a 115% increase since 2004. Overdose deaths on opioid pain relievers surpassed deaths from heroin and cocaine for the first time in 2008.

This rise of Opana abuse illustrates the adaptability of drug addicts and the never-ending challenge facing law enforcement authorities, addiction specialists and pharmaceutical companies. Just when they think they have curbed abuse and stopped trafficking of one drug, another fills the void. Opana's dangerous new popularity arose when OxyContin's manufacturer changed its formula to deter users from crushing, breaking or dissolving the pill so it could be snorted or injected to achieve a high.

As a new, harder-to-abuse Opana formulation replaces the old formula, police and addiction experts expect heroin to fill that void.

For years, drug abusers favored an extended-release version of OxyContin, a narcotic painkiller, for a powerful high. Over the past decade, its abuse was so prevalent that the drug became a household name.

Drug abusers could crush or dissolve the pill's time-release coating to get the full punch of the opioid oxycodone. But Purdue Pharma, OxyContin's manufacturer, reformulated it in August 2010, making it nearly impossible to crush, dissolve and inject. By the beginning of 2011, more than 95% of prescriptions were being filled with reformulated OxyContin, Purdue spokesman James Heins said.

Though people could still abuse the drug by taking larger quantities, some addicts craved the injectable high.

"At first, people tried to defeat it," McGuire said. "Then, Opana started to pop up like crazy."

Opana ER, an extended-release painkiller containing oxymorphone, came on the market in 2006. Endo Pharmaceuticals, the manufacturer, completed development of a crush-resistant pill in 2010 but did not get approval from the Food and Drug Administration (FDA) until late last year, said Endo senior vice president Blaine Davis.

On June 14, the FDA moved the old Opana formulation to its list of discontinued drugs. Davis said he doesn't know how much remains on the market.

Posted: 7/11/2012 12:27:00 PM

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Oxycodone toll in Florida spotlights prescription drug dangers

From CBS News:

New data shows Florida's prescription drug deaths have increased nearly 9 percent last year compared to 2009 despite an aggressive crackdown by law enforcement officials.

Oxycodone was the number one killer, causing 1,516 deaths in 2010, compared to 1,185 the year before. Overall, there were 2,710 deaths in Florida last year caused by prescription drugs, compared to 2,488 in 2009. For the second year in a row, prescription drugs continued to outpace illegal drugs as a cause of death - there were almost three times as many deaths in Florida last year attributed to oxycodone compared with cocaine.

Florida has been a leading source for the illicit purchase of prescription drugs, with addicts and dealers from across the Southeast flocking to clinics for fixes.

Posted: 8/17/2011 8:33:00 AM

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Prescription Painkillers: Companies Attempt Abuse-Proof Opioids

From ABC News:

When the oxycodone brand called OxyContin was introduced in the late 1990s, its maker claimed that the drug's controlled-release mechanism would make it less likely to be abused.

The idea was that if it released its opioid slowly, rather than all at once, abusers wouldn't find the immediate rush they crave.

But it didn't take long for drug seekers to devise a workaround that foiled that plan.

Chewing the tablet, crushing it, or dissolving and injecting it -- all destroyed the timed-release mechanism, which unpacked the full opioid punch faster than you could say, "Your brain on drugs."

Since that failed attempt at making a "safe" opioid, researchers have been experimenting with ways to make all prescription painkillers "abuse-resistant."

Although OxyContin maker Purdue had its "tamper-proof" version approved last year, few other attempts to abuse-proof these drugs have made it on the market.

In June, however, the FDA is expected to issue a decision about another oxycodone product -- Acurox, Pfizer's attempt (through the acquisition of King Pharmaceuticals) at entry into the abuse-proof market.

And a handful of other companies are pursuing a pharmacological solution to help mitigate what the federal government has described as an epidemic of prescription painkiller abuse.

Posted: 4/28/2011 8:18:00 AM

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FDA Heightens Painkiller Oversight

From The Wall Street Journal:

The Food and Drug Administration said Tuesday that it will require some painkiller manufacturers to produce new educational tools in an effort to quell prescription-drug abuse.

The requirements will affect makers of long-acting and extended-release opioids, which include oxycodone, morphine and methadone.

This plan will help shut down "pill mills" where addicts can receive illegal prescriptions, said Gil Kerlikowske, director of national drug-control policy.

Prescription-drug abuse results in one million emergency-room visits a year, Mr. Koh said. Opioid drugs resulted in more unintentional deaths than cocaine or heroin in 2007, according to the Centers for Disease Control and Prevention.

Posted: 4/19/2011 1:15:00 PM

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FDA warns makers of unapproved narcotics

From CNN:

Seeking to remove unapproved drugs from the marketplace, the Food and Drug Administration on Tuesday ordered nine companies to stop manufacturing narcotics whose therapeutic claims have not been proved.

The FDA's warning letters notified the companies they may be subject to legal action if they do not stop manufacturing and distributing "prescription unapproved products" that include high-concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone or oxycodone.

This action does not include oxycodone capsules. All of these drugs are used for pain relief and are forms of previously approved medications.

The agency says this is not a recall, but is instead a warning to manufacturers. The companies have 60 days to pull these pain-relief drugs from the market. Distributors have 90 days to stop shipping them.

If these drugs are not off the market by those deadlines, a company could face seizure of the narcotics and legal action.

Although the FDA does not know whether these drugs are unsafe, it has not approved them so cannot certify that the products are 100 percent safe and effective.

"Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

The FDA believes Americans have access to plenty of legal narcotics for pain relief and removing these unapproved drugs will not create a shortage.

Consumers who may be concerned that they are taking any unapproved drug products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. Those who find they are taking unapproved drugs should see their health care professionals for treatment options.